NCT03426540

Intravitreal Conbercept After Vitrectomy

Safety and Efficacy of Intravitreal Conbercept Injection After Vitrectomy for the Treatment of Early Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tianjin Medical University Eye Hospital · Academic / Other
• Sex: All
• Age: 28 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR). Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual outcomes of surgery for early-stage PDR.

Detailed description

The drug conbercept (an anti-vascular endothelial growth factors) was recently made available for management of early prolific diabetic retinopathy, but its safety and efficacy still require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early proliferative diabetic retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment group and control after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not. At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure and central retinal thickness will be measured and fundoscopy be performed. The patients are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, physical examinations and postoperative complications

Conditions

• Early Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Conbercept	Three-port 25-G PPV was performed in all patients using a Constellation system. Patients in the treatment group received an intravitreal injection of conbercept (10 mg/mL, 0.5 mg) using a sterile technique after 25-G vitrectomy.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-03-30
• Completion: 2019-02-28
• First posted: 2018-02-08
• Last updated: 2019-04-30